Accu-Tell ® Syphilis Rapid Test Strip/Cassette (Serum/ ...

Accu-Tell ® Syphilis Rapid Test Strip/Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in serum or plasma to aid in the diagnosis of Syphilis

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Product Description

Product Description

 

CATALOG

Product Name

Specimen

Catalog No.

Quantity per box

Certificate

Syphilis Strip

Serum/Plasma

ABT-STD-A17

           50T

CE

Syphilis Cassette

Serum/Plasma

ABT-STD-B17 

           25T

CE

 

 

KEY POINTS

Detection for: Antibodies (IgG and IgM) to Treponema Pallidum (TP) qualitatively in serum or plasma.

Specimen volume: 150μL Serum or Plasma specimen for test strip

                                 40 μL  Serum or Plasma specimen for test cassette

Reading time: 5 minutes

Relative sensitivity: >99.9% (95%CI*: 97.7%~100.0%);  

Relative specificity: 99.7% (95%CI*: 98.2%~100.0%);

Accuracy: 99.8% (95%CI*: 98.2%~100.0%).      

 

INTRODUCTION

Treponema Pallidum (TP) is the causative agent of the venereal disease Syphilis. TP is a spirochete bacterium with an outer envelope and a cytoplasmic membrane.Relatively little is known about the organism in comparison with other bacterial pathogens.

 

INTENDED USE

Accu-Tell® Syphilis Rapid Test Strip/Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in serum or plasma to aid in the diagnosis of Syphilis

 

TEST PROCEDURE

Test Cassette:

 

Test strips:

 

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1. Bring the pouch to room temperature before opening it. Remove the test Strip or test Cassette from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.

For test strip:

1.) Transfer 150μL serum or plasma to bottom of the test tube carefully. See the below illustration

With arrows pointing toward the serum or plasma specimen, immerse the test strip vertically into the specimen solution of the test tube and then start the timer. Do not pass the maximum line (MAX) on the test strip when immersing the test strip. See the illustration

2.) Leave the strip in the test tube and wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 20 minutes.

For test cassette:

Place the cassette on a clean and level surface.Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 40 μL) to the specimen well of the test cassette, then add 1 drop of buffer (approximately 40μL) and start the timer. Avoid trapping air bubbles in the specimen well. See the illustration below.

2. Wait for the colored line(s) to appear. Read results at 5 minutes.  Do not interpret the result after 20minutes.

 

 

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

Accu-Tell® Syphilis Rapid Test Strip/Cassette (Serum/Plasma) has correctly identified specimens of a seroconversion panel and has been compared to a leading commercial TPPA Syphilis test using clinical specimens. The results show that the relative sensitivity of Accu-Tell® Syphilis Rapid Test Strip/Cassette (Serum/Plasma) is >99.9% and the relative specificity is 99.7%.

Method TPPA Total Result Accu-Tell®   Syphilis Rapid Test Strip/Cassette (Serum/Plasma) Results Positive Negative Positive 130 1 131 Negative 0 299 299 Total Result 130 300 430

Relative sensitivity: >99.9% (95%CI*: 97.7%~100.0%);  

Relative specificity: 99.7% (95%CI*: 98.2%~100.0%);

Accuracy: 99.8% (95%CI*: 98.2%~100.0%).    

*Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 15 replicates of four specimens: a negative, a low positive, a medium positive and a high positive. The negative, low positive, medium positive and high positive values were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by 15 independent assays on the same four specimens: a negative, a low positive, a medium positive and a high positive. Three different lots of Accu-Tell® Syphilis Rapid Test Strip/Cassette (Serum/Plasma) have been tested over a 3-day period using negative, low positive, medium positive and high positive specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity

Accu-Tell® Syphilis Rapid Test Strip/Cassette (Serum/Plasma) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, HCV,HIV, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity.

Interfering Substances

The following potentially interfering substances were added to Syphilis negative and positive specimens.

Acetaminophen:                  20 mg/dL                             Caffeine:          20 mg/dL

Acetylsalicylic Acid:             20 mg/dL                             Gentisic Acid:  20 mg/dL

Ascorbic Acid:                           2g/dL                              Albumin:              2 g/dL

Creatin:                             200 mg/dL                              Hemoglobin   1.1 mg/dL

Bilirubin:                                   1g/dL                               Oxalic Acid:    600mg/dL

None of the substances at the concentration tested interfered in the assay.

 

LIMITATIONS

1. Accu-Tell® Syphilis Rapid Test Strip/Cassette (Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of TP antibodies in serum or plasma specimens only. Neither the quantitative value nor the rate of increase in TP antibodies can be determined by this qualitative test.

2. Accu-Tell® Syphilis Rapid Test Strip/Cassette (Serum/Plasma) will only indicate the presence of TP antibodies in the specimen and should not be used as the sole criteria for the diagnosis of TP infection.

3. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.

4. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of TP infection.

 

 

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.

 

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